Clinical trial for High Intensity Interval Training (HIT) after bariatric surgery
Organizational Data
- DRKS-ID:
- DRKS00024939
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-09-20
- Last update in DRKS:
- 2023-11-22
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
This clinical trial will be investigating, whether a four-week High intensity interval training (HIT) is possible 8 weeks after bariatric surgery on a bicycle. Also, it will be investigated whether a certain training protocol has higher compliance levels than others. Furthermore, physical fitness of patients in intervention groups will be compared to a group without intervention. For this purpose, 22 patients will be assigned 3 different training groups or one group without intervention. We will monitor physical fitness via bicycle ergometry and lactate tolerance testing. Inflammatory markers and nutritional status will be monitored via blood draws.
Brief summary in scientific language
This clinical trial is designed as a pilot trial and will be investigating a four-week HIT 8 weeks after bariatric surgery. The goal of this trial is to identify changes in physical fitness, nutritional status, inflammatory markers and whether feasibility of HIT is given after surgery. Bicycle ergometry, lactate tolerance and Borg's scale will be used for monitoring of physical fitness. Peripheral blood samples will be used for inflammatory markers and nutritional status. Patients will be divided into a four-arm study protocol including three intervention groups and one control group.
Health condition or problem studied
- ICD10:
- E66.0 - Obesity due to excess calories
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- No Intervention
- Arm 2:
- Four-week training protocol 3 times per week: 24 Intervals 20 sec VO2max 95% in exchange with 40 sec VO2max 70%
- Arm 3:
- Four-week training protocol 3 times per week: 12 Intervals 40 sec 95% VO2max in exchange with 70 sec 75% VO2max
- Arm 4:
- Four-week training protocol 3 times per week: 8 Intervals 60 sec 95% VO2max in exchange with 90 sec 70% VO2max
Endpoints
- Primary outcome:
- Feasibility of a training protocol defined via completion of all trainings with a missing out or early termination of a maximum of four training units in total
- Secondary outcome:
- Chance in lactate tolerance, Change in bicycle ergometry maximum strength and heart rate, Change in Borg's scale, Change of nutritional status and inflammatory markers measured in peripheral blood draws
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Mannheim Mannheim
Recruitment period and number of participants
- Planned study start date:
- 2021-03-31
- Actual study start date:
- 2021-06-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 88
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- - Planned Roux-en-Y Gastric bypass or sleeve gastrectomy as bariatric surgery at University Hospital Mannheim - Male and female patients between the ages of 18 and 80 years - written consent - physical ability to complete a bicycle ergometry test - BMI >/= 35 kg/m^2 in combination with a relevant comorbidity as mentioned in the S3 guidelines for obesity or BMI >/= 40kg/m^2
Exclusion Criteria
- Participation in another clinical trial interfering with this trial - physical disability not allowing training sessions (e.g. Arthritis, muscular disease) - Pregnancy and breastfeeding - severe cardiac or pulmonary disease - expected non-compliance - language barrier or failed consent
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum MannheimAlida FinzeTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 06213832225
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Contact for Public Queries
- Address:
- Universitätsklinikum MannheimAlida FinzeTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 06213832225
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Principal Investigator
- Address:
- Universitätsklinikum MannheimAlida FinzeTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 06213832225
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Chirurgische Klinik Universitätsmedizin MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 06213832225
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Ethics Committee
Address Ethics Committee
- Address:
- Medizinische Ethik-Kommission II Medizinischen Fakultät Mannheim, Forschungsgebäude, Haus 42 - Ebene 3Theodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49-621-38371770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-12-12
- Ethics committee number:
- 2020-680N
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-02-16
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Studienprotokoll HIT BAR
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry